Systems for determining, and devices for indicating, viable life of replaceable components thereof and methods therefor

ABSTRACT

A system capable of monitoring a replaceable component is provided. The system includes a controller for controlling operation of the system; programming instructions according to which the system is configured to: accept input of a viable life for the component, calculate an accumulated amount of distress experienced by the component based on each set of previously collected use data associated with each previous use of the component, and determine, based in part on the accumulated amount of distress, a used portion of the viable life that the component has experienced as a result of the previous use(s) thereof and an unused portion of the viable life; and a feedback device configured to provide to an operator of the system an indication of at least one of the unused and used portions of the viable life of the component. Methods of monitoring a replaceable component of a system are also provided.

BACKGROUND Field

This disclosure relates to fluid injectors and fluid delivery systemsand, in particular, to systems and methods for monitoring or trackingthe remaining or unused viable life of replaceable injector componentsduring fluid injection procedures.

Description of Related Art

Some diagnostic and therapeutic procedures involve injecting a fluid,such as a therapeutic agent, contrast agent, or nutrient solution to apatient. In recent years, a number of medical fluid delivery systems forpressurized injection of fluids, such as a contrast solution (oftenreferred to simply as “contrast”), a flushing agent, such as saline, andother medical fluids, have been developed for use in procedures such asangiography, computed tomography (CT), ultrasound, magnetic resonanceimaging (MRI), positron emission tomography (PET), and other molecularimaging procedures. In general, these medical fluid delivery systems aredesigned to deliver a preset amount of fluid at a preset flow rate.

In some injection procedures, a medical practitioner places a catheteror needle into a vein or artery of the patient. The catheter or needleis connected to a manual or an automatic fluid injector system by way oftubing and a connector that interfaces with the fluid injector system.Automatic fluid injector systems typically include at least one syringeconnected to at least one fluid injector having, for example, a poweredlinear piston. The at least one syringe includes, for example, a sourceof contrast and/or a source of flushing fluid The medical practitionerenters settings (referred to herein as “injection parameter settings”)into an electronic control system of the fluid injector for a fixedvolume of contrast and/or saline and a fixed rate of injection.

The injector device can include a Multi-Use Disposable fluid path Set(“MUDS”) with tubing and connectors for transporting fluid from thesyringe to an outflow port of the injector. The MUDS tubing andconnectors are generally formed from flexible plastic materials thatdeform or degrade with repeated use. The MUDS can be connected to asingle-use disposable set (SUDS) for transporting fluid from the MUDS tothe patient.

System operators must monitor and document use of the MUDS to determinewhen it needs to be removed and replaced. For example, a reusablecomponent such as the MUDS may need to be replaced every 12, 24, or 48hours. Alternatively, the MUDS may be scheduled to be replaced followinga specified number of injection procedures. However, determining whenthe MUDS or other components should be replaced can be difficult sincethe injector can be used by different operators or during multipleshifts during the lifespan of the MUDS or other components. Currently,operators monitor MUDS lifespan by recording when a MUDS is installedand a number of uses on a tag or label attached to the injector or MUDS.For example, the injector operator might write the date and time foreach use in an appropriate line on the label or tag. Once all availablespaces for writing the date and time are filled in, the MUDS should beremoved and replaced. However, such manual recording methods requireinjector operators to diligently check and update the label or tag priorto and following each injection activity.

In order to ensure proper function and performance throughout thelifecycle of the replaceable component, the components, such as theMUDS, are typically manufactured to withstand the maximum pressure andflow volumes that they would likely experience throughout theirrespective lifecycles. Accordingly, replaceable components aremanufactured with pressure tolerances far beyond actual levels appliedduring a conventional injection procedure. The SUDS is also manufacturedto withstand forces in excess of the maximum pressure and flow rate thatit would encounter during normal usage. However, since the SUDS is onlyused by a single patient and then discarded, the risk of rupture orfailure is reduced.

While various manual and automatic fluid delivery systems are known inthe medical field, improved fluid delivery systems adapted for use inmedical diagnostic and therapeutic procedures are desirable. Inparticular, injector systems with self-monitoring functions that arecapable of monitoring the status of replaceable injector components,such as the MUDS, and of providing a visual indication or representationof lifecycle for the replaceable injector components are needed.Providing a visual indication of lifecycle would help to preventdistress to the injector from worn out, replaceable components byproviding a more accurate and sophisticated indication of when suchreplaceable components should be removed and replaced.

SUMMARY

In view of the foregoing, a need exists for a fluid delivery systemincluding an injector associated with a controller, computing unit, orremote computer device that tracks the lifecycle of disposable and/orreplaceable injector components, such as the MUDS, and providesappropriate feedback to a system operator regarding the same. The systemshould be capable of monitoring or tracking remaining viable life forthe replaceable injector components based on calculated accumulated orestimated amount of distress that the replaceable component is subjectedto as a result of actual (or planned) injection procedures. Thecalculated accumulated or estimated amounts of distress can bedetermined based on a combination of experimental data about thereplaceable components, data provided from sensors positioned throughoutthe injector that are configured to measure injection forces and/ordistress to the replaceable injector components, and injection parametersettings and related information from the electronic control system ofthe fluid delivery system.

The fluid delivery system can also be integrated with other injectorcontrol systems to prevent the injector from performing an injection atforces, pressures, and flow rates exceeding those which the replaceableinjector component can withstand, based on the replaceable injectorcomponent's remaining or unused viable life and any identifiedaccumulated distress. As a result, the likelihood that an injectorcomponent will fail during use is significantly reduced since the useris alerted when cumulative distress reaches substantial levels. Further,manufacturing and design requirements for the replaceable injectorcomponents can be reduced since injector forces can be more accuratelymatched to maximum levels that the replaceable injector component canwithstand. Specifically, reusable components need not be manufactured towithstand maximum injector forces for the entire lifespan of thereusable component, as is currently required.

According to an aspect of the disclosure, a method of monitoring astatus of a replaceable component of a fluid injector includes:providing a viable life for a replaceable component of a fluid injector;calculating an accumulated amount of distress experienced by thereplaceable component based on each set of previously collectedinjection parameter data associated with each injection procedurepreviously performed on one or more patients therewith; determining,based in part on the accumulated amount of distress, a used portion ofthe viable life that the replaceable component has experienced as aresult of the previously performed injection procedures and, therewith,an unused portion of the viable life; and providing to an operator ofthe fluid injector an indication of at least one of the unused and usedportions of the viable life of the replaceable component.

In some examples, the injection parameter data can include one or moreof an injection pressure, an injection time, and an injectiontemperature. The accumulated amount of distress can be calculated usingat least an algorithm that employs a model descriptive of materialdegradation of the replaceable component. The model can be based, forexample, on Miner's Rule or on an Inverse Power Law-Weibull Model.

In some examples, the injection parameter data can include datacollected from multiple portions of the fluid injector. In addition,providing to the operator of the fluid injector an indication of theunused and/or used portions of the viable life can include displaying avisual representation of the used portion of the viable life relative tothe viable life of the replaceable component. The viable life of thereplaceable component can be determined before the replaceable componentis installed on the fluid injector.

According to another aspect of the disclosure, a fluid delivery systemcapable of monitoring a replaceable component thereof includes: a fluidinjector; at least one replaceable component for use with the fluidinjector; a controller; and a visual and/or audio feedback device. Thecontroller can be configured to: obtain a viable life for the at leastone replaceable component; calculate an accumulated amount of distressexperienced by the replaceable component based on each set of previouslycollected injection parameter data associated with each injectionprocedure previously performed on one or more patients using the fluidinjector; and determine, based in part on the accumulated amount ofdistress, a used portion of the viable life that the replaceablecomponent has experienced as a result of the previously performedinjection procedures and an unused portion of the viable life. Thevisual and/or audio feedback device can be configured to provide to anoperator of the fluid injector an indication of the unused and/or usedportions of the viable life of the replaceable component.

In some examples, the at least one replaceable component comprises adisposable multi-patient fluid path set. In addition, the fluid deliverysystem can include a sensing or timing device associated with a portionof the fluid injector and configured to collect the injection parameterdata.

According to another aspect of the disclosure, a system for monitoring areplaceable component of an apparatus is provided. The system includes:a controller for controlling operation of an apparatus being monitoredby the system and programming instructions operably associated with thecontroller. The programming instructions, when executed, cause thecontroller to: accept input of a viable life for a replaceable componentof the apparatus; calculate an accumulated amount of distressexperienced by the replaceable component based on each set of previouslycollected use data associated with each previous use of the replaceablecomponent by the apparatus; and determine, based in part on theaccumulated amount of distress, a used portion of the viable life thatthe replaceable component has experienced as a result of the previoususe or uses thereof and an unused portion of the viable life. The systemalso includes a visual and/or audio feedback device configured toprovide to an operator of the apparatus an indication of at least one ofthe unused and used portions of the viable life of the replaceablecomponent.

In some examples, the apparatus includes at least one of an infusiondevice and a centrifuge separator. In that case, the controller can beconfigured to control operation of the at least one of the infusiondevice and the centrifuge separator. The replaceable component, which isassociated with the infusion device and/or the centrifuge separator, canbe at least one of a syringe, a tubing set, a valve, a fluid connector,or any combination thereof.

According to another aspect of the disclosure, a method of monitoring astatus of a replaceable component of a fluid injector includes:providing a viable life for the replaceable component; collecting apresent set of injection parameter data associated with a plannedinjection procedure to be performed with the replaceable component;calculating an estimated amount of distress that would be experienced bythe replaceable component if the planned injection procedure were to beperformed in accordance with the present set of injection parameterdata; determining, based in part on the estimated amount of distress, aportion of the viable life that would be experienced by the replaceablecomponent if the planned injection procedure were to be performed and,as a result, the replaceable component were to incur the estimatedamount of distress; comparing the viable life of the replaceablecomponent to the portion of the viable life that would be experienced bythe replaceable component if the planned injection procedure were to beperformed; and providing an indication of a result of the comparison toan operator of the fluid injector.

In some examples, the injection parameter data can include one or moreof an injection pressure, an injection time, and an injectiontemperature. In addition, the estimated amount of distress can becalculated using at least an algorithm that employs a model descriptiveof material degradation of the replaceable component. The model can bebased, for example, on Miner's Rule or on an Inverse Power Law-WeibullModel.

In some examples, the injection parameter data can include datacollected from multiple portions of the fluid injector. In addition,providing an indication of a result of the comparison can includedisplaying a visual representation of the used portion of the viablelife relative to the viable life of the replaceable component. Theviable life of the replaceable component can be determined before thereplaceable component is installed on the fluid injector.

According to another aspect of the disclosure, a method of monitoring astatus of a replaceable component of a fluid injector includes:providing a viable life for the replaceable component; calculating anaccumulated amount of distress experienced by the replaceable componentbased on each set of previously collected injection parameter dataassociated with each injection procedure previously performed therewith;collecting a present set of injection parameter data associated with aplanned injection procedure to be performed with the replaceablecomponent; calculating an estimated amount of additional distress thatwould be experienced by the replaceable component if the plannedinjection procedure were to be performed in accordance with the presentset of injection parameter data; determining, based in part on theaccumulated amount of distress, a used portion of the viable life thatthe replaceable component has experienced as a result of the previouslyperformed injection procedures and, therewith, an unused portion of theviable life; determining, based in part on the estimated amount ofadditional distress, an additional portion of the viable life that wouldbe experienced by the replaceable component if the planned injectionprocedure were to be performed and, as a result, the replaceablecomponent were to incur the estimated amount of additional distress;comparing at least one of the unused and used portions of the viablelife of the replaceable component to the additional portion of theviable life that would be experienced by the replaceable component ifthe planned injection procedure were to be performed; and providing anindication of a result of the comparison to an operator of the fluidinjector.

In some examples, the injection parameter data can include one or moreof an injection pressure, an injection time, and an injectiontemperature. The estimated and the accumulated amounts of distress caneach be calculated using at least an algorithm that employs a modeldescriptive of material degradation of the replaceable component. Themodel can be based, for example, on Miner's Rule or on an Inverse PowerLaw-Weibull Model. The injection parameter data can include datacollected from multiple portions of the fluid injector.

In some examples, providing an indication of a result of the comparisoncan include displaying a visual representation of the used portion ofthe viable life relative to the viable life of the replaceablecomponent. The viable life of the replaceable component can bedetermined, for example, before the replaceable component is installedon the fluid injector.

In some examples, the accumulated amount of distress experienced by thereplaceable component will initially be zero when no injection procedurehas been previously performed therewith and the planned injectionprocedure will be intended as the first to be used therewith.

According to yet another aspect of the disclosure, a system capable ofmonitoring a replaceable component thereof is provided. The systemincludes: a controller for controlling operation of the system andprogramming instructions operably associated with the controller. Theprogramming instructions, when executed, cause the system to: acceptinput of a viable life for a replaceable component of the system;calculate an accumulated amount of distress experienced by thereplaceable component based on each set of previously collected use dataassociated with each previous use of the replaceable component by thesystem; and determine, based in part on the accumulated amount ofdistress, a used portion of the viable life that the replaceablecomponent has experienced as a result of the previous use or usesthereof and an unused portion of the viable life. The system alsoincludes a visual and/or audio feedback device configured to provide toan operator of the system an indication of at least one of the unusedand used portions of the viable life of the replaceable component.

In some examples, the system is a fluid delivery system comprising afluid injector. In that case, the use data associated with each previoususe of the replaceable component by the system is injection parameterdata associated with each injection procedure previously performed onone or more patients using the fluid injector, wherein the injectionparameter data includes one or more of an injection pressure, aninjection time, and an injection temperature. In addition, thereplaceable component can include a syringe, a tubing set, a valve, afluid connector, a multi-patient fluid path set, a single-patient fluidpath set or any combination thereof. The system can also include asensing or timing device associated with a portion of the fluid injectorand configured to collect the injection parameter data.

According to another aspect of the disclosure, a disposable lifeindicator for measuring cumulative fluid pressure for a fluid injectorincludes: a fluid collecting portion in fluid communication with a fluidset of a fluid injector; and a gauge configured to indicate to a user aused and/or an unused viable life for a replaceable component of thefluid injector based on a volume of fluid in the fluid collectingportion.

In some examples, the disposable life indicator also includes a checkvalve disposed between the fluid set of the fluid injector and the fluidcollecting portion. The check valve can be configured to permit fluidflow above a threshold pressure to access the fluid collecting portion.The check valve can be a one-way check valve.

In some examples, the disposable life indicator also includes a flowrestrictor positioned between the fluid set and the fluid collectingportion for reducing velocity of a fluid flow entering the fluidcollecting portion. The flow restrictor can include a porous filter. Inaddition, the gauge can include a piston moveably disposed within a boreof the gauge and configured to move therethrough as the volume of fluidin the fluid collecting portion increases. The piston can have aconspicuous tip configured to extend beyond an open distal end of thegauge in an end-of-use position. In other examples, the gauge caninclude a bourdon tube.

These and other features and characteristics of certain and non-limitingembodiments, as well as the methods of operation and functions of therelated elements of structures and the combination of parts andeconomies of manufacture, will become more apparent upon considerationof the following description and the appended claims with reference tothe accompanying drawings, all of which form a part of thisspecification, wherein like reference numerals designate correspondingparts in the various figures. It is to be expressly understood, however,that the drawings are for the purpose of illustration and descriptiononly and are not intended as a definition of the limits of theinvention. As used in the specification and the claims, the singularform of “a”, “an”, and “the” include plural referents unless the contextclearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and other objects and advantages will become apparentfrom the following detailed description made with reference to thedrawings in which:

FIG. 1 is a perspective view of a multi-fluid delivery system (referredto herein as “an injector”), according to one aspect of the disclosure;

FIG. 2 is schematic view of various fluid paths within the injector ofFIG. 1;

FIG. 3A is a perspective view of a life indicator, in a full or unusedposition, connected to a fluid path set, according to an aspect of thedisclosure;

FIG. 3B is cross section view of the life indicator and fluid path setof FIG. 3A in a full or unused position;

FIG. 4A is a perspective view of the life indicator of FIG. 3A in anend-of-life position;

FIG. 4B is a cross section view of the life indicator of FIG. 4A in theend-of-life position;

FIG. 5 is a schematic drawing of a bourdon tube life indicator accordingto another aspect of the disclosure;

FIG. 6 is a schematic drawing of a life indicator according to anotheraspect of the disclosure;

FIG. 7 is a schematic drawing of a life indicator according to anotheraspect of the disclosure;

FIG. 8 is a schematic drawing of a fluid delivery system including theinjector of FIG. 1, according to an aspect of the disclosure;

FIG. 9A is a flow chart illustrating steps for monitoring a fluiddelivery system, according to an aspect of the disclosure;

FIG. 9B is a flow chart illustrating steps for monitoring a fluiddelivery system in which a first (e.g., a sole or present) use of areplaceable component is considered;

FIG. 9C is a flow chart illustrating steps for monitoring a fluiddelivery system in which both previous and present uses of thereplaceable component are considered;

FIG. 10 is a feedback indicator for the fluid delivery system of FIG. 8;and

FIG. 11 is a schematic view of an electronic control device for use withthe fluid delivery system of FIG. 8, in accordance with an aspect of thedisclosure.

DESCRIPTION

For purposes of the description hereinafter, the terms “end”, “upper”,“lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”,“lateral”, “longitudinal” and derivatives thereof shall relate to theinvention as it is oriented in the drawing figures. However, it is to beunderstood that the invention may assume various alternative variationsand step sequences, except where expressly specified to the contrary. Itis also to be understood that the specific devices and processesillustrated in the attached drawings, and described in the followingspecification, are simply exemplary embodiments of the invention. Hence,specific dimensions and other physical characteristics related to theembodiments disclosed herein are not to be considered as limiting.

As used herein, the terms “communication” and “communicate” refer to thereceipt or transfer of one or more signals, messages, commands, or othertypes of data. For one unit or component to be in communication withanother unit or component means that the one unit or component is ableto directly or indirectly receive data from and/or transmit data to theother unit or component. This can refer to a direct or indirectconnection that may be wired and/or wireless in nature. Additionally,two units or components may be in communication with each other eventhough the data transmitted may be modified, processed, routed, and thelike, between the first and second unit or component. For example, afirst unit may be in communication with a second unit even though thefirst unit passively receives data, and does not actively transmit datato the second unit. As another example, a first unit may be incommunication with a second unit if an intermediary unit processes datafrom one unit and transmits processed data to the second unit. It willbe appreciated that numerous other arrangements are possible.

The present disclosure is generally directed to a fluid injector system100 (shown in FIGS. 1, 2, and 8) and associated monitoring system 10(shown in FIG. 8) that monitors or tracks the status and remaining orunused viable life of one or more replaceable and disposable componentsof the injector 100, such as the MUDS, syringes, fluid sources,connectors, valves, and other components (referred to hereincollectively as “the replaceable injector components”). The monitoringsystem 10 provides feedback to an operator thereof about the remainingor unused viable life of the replaceable component(s) and, in certaincircumstances, issues an alert if one of the replaceable componentsreaches the end of its anticipated useful life. The replaceablecomponents are often at least partially formed from plastic materials,which degrade or deform when subjected to substantial force or pressureover time, such as pressure provided as the injector 100 forces fluidthrough the replaceable injector components. The monitoring system 10 isconfigured to collect information about injector use and, based on thecollected information, estimate and/or determine remaining or unusedviable life of a replaceable component based on data from priorinjections. As is discussed herein, the monitoring system 10 can controloperation of the injector 100 and reduce injection force or entirelyprevent an injection from being performed if the replaceable injectorcomponents are determined to be unsuitable to withstand an expectedinjection pressure.

Fluid Injector

With reference to FIG. 1, the fluid injector 100 is configured todeliver fluid to a patient through a MUDS 130 (shown in FIGS. 2 and 8)in fluid communication with a single-use disposable set (SUDS) 190(shown in FIG. 2). The fluid injector 100 includes an injector housing102 having opposed lateral sides 104, a distal or upper end 106, and aproximal or lower end 108. In some embodiments, the housing 102 can besupported on a base 110 having one or more wheels 112 for rotatable andmovable support of the housing 102 on a floor surface. The one or morewheels 112 can be lockable to prevent the housing 102 from inadvertentlymoving once positioned at a desired location. At least one handle 114can be provided to facilitate moving and positioning the fluid injector100. In other embodiments, the housing 102 can be removably ornon-removably secured to a fixed surface, such as a floor, ceiling,wall, or other structure. The housing 102 encloses the variousmechanical drive components, electrical and power components necessaryto drive the mechanical drive components, and control components, suchas electronic memory and electronic control devices, used to controloperation of reciprocally movable piston elements 103 (shown on FIG. 2)associated with the fluid injector 100. Such piston elements 103 can bereciprocally operable via electro-mechanical drive components such as aball screw shaft driven by a motor, a voice coil actuator, arack-and-pinion gear drive, a linear motor, and the like. In someembodiments, at least some of the mechanical drive components,electrical and power components, and control components can be providedon the base 110 portion of the injector 100.

The fluid injector 100 includes at least one bulk fluid connector 118for connection with at least one bulk fluid source 120. In someembodiments, a plurality of bulk fluid connectors 118 can be provided.For example, as shown in FIG. 1, three bulk fluid connectors 118 can beprovided in a side-by-side or other arrangement. In some embodiments,the at least one bulk fluid connector 118 can be a spike configured forremovably connecting to the at least one bulk fluid source 120, such asa vial, a bottle, or a bag. The at least one bulk fluid connector 118can have a reusable or non-reusable interface with each new bulk fluidsource 120. The at least one bulk fluid connector 118 can be formed onthe MUDS 130 (shown in FIG. 2), as described herein. The at least onebulk fluid source 120 can be configured for receiving a medical fluid,such as saline, contrast solution, or other medical fluid, for deliveryto the fluid injector system 100. The housing 102 can have at least onesupport member 122 for supporting the at least one bulk fluid source 120once it is connected to the fluid injector system 100.

With continued reference to FIG. 1, the fluid injector system 100includes one or more user interfaces 124, such as a graphical userinterface (GUI) display window. The user interface 124 can displayinformation pertinent to a fluid injection procedure performed by thefluid injector 100, such as current flow rate, fluid pressure, andvolume remaining in the at least one bulk fluid source 120 connected tothe fluid injector 100, and can be a touch screen GUI that allows anoperator to input commands and/or data for operation of the fluidinjector system 100. While the user interface 124 is shown in FIG. 1 onthe injector housing 102, the user interface 124 can also be in the formof a remote display that is wired or wirelessly linked to the housing102 and can control mechanical elements of the fluid injector 100. Insome embodiments, the user interface 124 can be a tablet that isdetachably connected to the housing 102 and is in wired or wirelesslylinked communication with the housing 102. Additionally, the fluidinjector system 100 and/or user interface 124 can include at least onecontrol button 126 for tactile operation by an attendant operator of thefluid injector system 100.

Having generally described the injector 100, the MUDS 130, which isconfigured to be removably connected to the fluid injector 100 will nowbe discussed in detail. With reference to FIG. 2, the MUDS 130 deliversone or more fluids from the one or more bulk fluid sources 120 to thepatient. The MUDS 130 can include one or more syringes 132 and pistonelements 103. In some embodiments, the number of syringes 132 cancorrespond to the number of bulk fluid sources 120. For example, withreference to FIG. 2, the MUDS 130 has three syringes 132 in aside-by-side arrangement such that each syringe 132 is fluidlyconnectable to one of the bulk fluid sources 120. In some embodiments,one or two bulk fluid sources 120 can be connected to one or moresyringes 132 of the MUDS 130. Each syringe 132 can be fluidlyconnectable to one of the bulk fluid sources 120 by a corresponding bulkfluid connector 118 and an associated MUDS fluid path 134. The MUDSfluid path 134 can have a spike element that connects to the bulk fluidconnector 118. In some embodiments, the bulk fluid connector 118 can beprovided directly on the MUDS 130.

The MUDS 130 can include one or more valves 136, such as stopcockvalves, for controlling which medical fluid or combinations of medicalfluids are withdrawn from the multi-dose bulk fluid source 120 and/orare delivered to a patient through each syringe 132. In someembodiments, one or more valves 136 can be provided either on thesyringe 132 or on a manifold 148. The manifold 148 can be in fluidcommunication via valves 136 and/or syringes 132 with a first end of theMUDS fluid path 134 that connects each syringe 132 to the correspondingbulk fluid source 120. The opposing second end of the MUDS fluid path134 can be connected to the respective bulk fluid connector 118 that isconfigured for fluidly connecting with the bulk fluid source 120.

With continued reference to FIG. 2, in some embodiments, the fluidoutlet line 152 can also be connected to a waste reservoir 156 on thefluid injector system 100. The waste reservoir 156 is desirably separatefrom the syringes 132 to prevent contamination. In some embodiments, thewaste reservoir 156 is configured to receive waste fluid expelled fromthe syringes 132 during, for example, a priming operation. The wastereservoir 156 can be removable from the housing 102 in order to disposeof the contents of the waste reservoir 156. In other embodiments, thewaste reservoir 156 can have a draining port (not shown) for emptyingthe contents of the waste reservoir 156 without removing the wastereservoir 156 from the housing 102. In some embodiments, the wastereservoir 156 is provided as a separate component from the MUDS 130.

Disposable Life Indicators

Having described the fluid injector 100 and MUDS 130, with reference toFIGS. 3A-7, a disposable life indicator 50, which can be associatedwith, connected to, or integrally formed with a portion of thereplaceable component, such as the MUDS fluid path 134, will now bediscussed in detail. The disposable life indicator 50 can be attached toa port 52 extending from the fluid path 134 and in fluid communicationwith the fluid path 134 through a narrow channel 54 (shown in FIGS. 3Band 4B). The port 52 can include any suitable connector, as is known inthe art, for connecting the indicator 50 to the fluid path 134including, but not limited to, a luer connector, a snap fit connector,threaded connectors, or combinations thereof. The disposable lifeindicator 50 is a mechanical device or mechanism configured to indicateto a user or injector operator a cumulative pressure exerted on thereplaceable component, such as the MUDS 130, and, in particular, toindicate to the user or injector operator when the replaceable componentreaches the end of its lifecycle and should be replaced. In general, thedisposable life indicator 50 includes an advancing structure, such as apiston or dial, which transitions from a full or unused position,indicating that the replaceable component is unused and in a like-newcondition, to an empty or end-of-use position, indicating that thereplaceable component has been exposed to maximum cumulative fluidpressure and should be replaced. The user or injector operator isinstructed to remove and replace the replaceable component when theadvancing structure is in its end-of-use position. The disposable lifeindicator 50 can be a single use disposable device that is replaced atthe same time as the replaceable component.

With specific reference to FIGS. 3B and 4B, in one embodiment, the lifeindicator 50 is inserted in and extends from the port 52, and includes agauge 62 with a piston 70 positioned therein to move within a bore of,or through a barrel of, the gauge 62 to indicate cumulative pressure.The indicator 50 includes a high pressure one-way check valve 56, suchas an elastomeric cylinder, defining an inner channel 58 seated againsta proximal end of the retainer 60. The valve 56 prevents fluid at lowpressure from entering the indicator 50. Specifically, since lowpressure fluid flows have negligible effect on the structural integrityof the replaceable component or MUDS 130, the check valve 56 isconfigured to prevent such low pressure fluid flows from contributing toadvancement of the piston 70. The check valve 56 is configured to openat a threshold pressure, which is a pressure sufficient to affect thereplaceable component, and to prevent lower pressure fluid flows frompassing through the valve 56.

The retainer 60, such as an insert or housing, includes a hollowcylindrical portion for receiving the gauge 62 of the life indicator 50,and is positioned adjacent to and/or pressed against the check valve 56.A flow restrictor 64 is inserted in a proximal end of the retainer 60.The flow restrictor 64 is provided to disrupt high pressure fluid flowsfrom entering the gauge 62 of the indicator 50 to prevent distress tothe gauge 62 from fluid flowing through the check valve 56. For example,the flow restrictor 64 can be a porous filter with a plurality oftortuous flow passages. Directing fluid through the tortuous passagesreduces flow rate as the fluid advances towards the gauge 62.

The gauge 62 is at least partially received in the retainer 60 andextends from a distal end thereof. The gauge 62 includes a fluidcollecting portion 66 at a proximal end thereof, and a movableindicating structure, such as the piston 70, which is slideably receivedwithin the barrel/bore of the gauge 62. The piston 70 advances throughthe barrel of the gauge 62 as fluid collects in the fluid collectingportion 66. The piston 70 can have a conspicuous end-of-use portion 72,such as a colored tip, that is configured to extend from the barrel ofthe gauge 62 and thus is easily visible when the maximum cumulativepressure is reached and/or exceeded. In some embodiments, the gauge 62can include various graduations or markings (not shown in FIGS. 3A-4B)for showing how far the piston 70 has advanced through the gauge 62. Forexample, markings can indicate to the injector operator an estimatednumber of injections remaining before the replaceable component must bereplaced, an estimated total number of injections performed already, orother relevant information. Alternatively, in some embodiments, thegauge 62 can be an electronic volume sensor configured to measure fluidcollected in the fluid collecting portion 66 of the gauge 62. A signalfrom the volume sensor can be sent to a controller or user interface ofthe injector for providing data to the operator regarding cumulativepressure level.

In other embodiments, the gauge 62 can include an electronic indicator.For example, the gauge 62 can include a light, such as an LED bulb,configured to light up when the piston 70 reaches its end-of-useposition. The electronic indicator or LED bulb can be located on thelife indicator 50, on the fluid injector 100, or at a remote location.Further, graduations or markings on the gauge 62 barrel can includeelectronic indicators, such as LED bulbs, configured to light up whenthe piston 70 reaches a particular position within the gauge 62. Inother embodiments, the electronic indicator can be a verbal or audioindicator, such as an alarm that sounds when the piston 70 advances tothe end-of-use position and should be replaced.

In use, as pressurized fluid flows through the MUDS fluid path 134, asmall volume of fluid is diverted into the narrow channel 54 of the port52 and toward the gauge 62. If the fluid flow is sufficient to open theone-way check valve 56, fluid passes through the valve 56 and into theretainer 60. The fluid is prevented from flowing back into the MUDSfluid path 134 by the valve 56. After passing through the valve 56, thefluid is directed though the flow restrictor 64 and into the fluidcollecting portion 66 of the gauge 62. As the volume of collected fluidincreases, the piston 70 is driven through barrel of the gauge 62,thereby providing a cumulative indication of pressure exerted on thereplaceable or disposable injector component. It is noted that when lowpressure fluid flow passes through the MUDS fluid path 134, the valve 56remains closed and no new fluid is provided to advance the piston. Asshown in FIGS. 3A and 3B, in the unused or full position, the piston 70is initially seated against the proximal end of the gauge 62. As fluidvolume in the fluid collecting portion 66 increases, the piston 70 isdriven through the gauge 62 toward the distal end thereof. As shown inFIGS. 4A and 4B, in the end-of-use position, the end-of-use portion 72extends beyond the distal end of the gauge 62.

With specific reference to FIG. 5, in another embodiment of theindicator 50, the gauge is a bourdon tube arrangement 74. The bourdontube arrangement 74, which resembles a standard gas gauge for a gasolinepowered vehicle, includes a flexible tube 76 and an arm 78 driven by apinion 80 and biasing spring 82. The pinion 80 and biasing spring 82 arepivotally engaged to the tube 76. A proximal end of the tube 76 isconnected to and receives pressurized fluid from the MUDS fluid path 134through the narrow channel 54 of the port 52. As the volume ofpressurized fluid in the tube 76 increases, the tube 76 exerts a forceon the pinion 80 and biasing spring 82 causing the arm 78 to transitionfrom the unused or full position to the empty or end-of-life position. Astop 84 located adjacent to the proximal end of the tube 76 indicateswhen the reusable component reaches the end of its expected life.

In addition to the above-described piston and bourdon tube mechanisms,the indicator 50 can include other electronic or mechanical mechanismsor devices or gauges, as are known in the art, for indicating that fluidis being collected from the fluid path 134. For example, the mechanismcan be an inflatable balloon. As the injector is in use, fluid collectsin the balloon. The balloon is permitted to continue to expand until aparticular size or inflation level is obtained, which signifiesend-of-use for the replaceable component. In another embodiment, acoiled balloon or tube, such as a party horn, can be configured tounfurl as fluid collects therein. The horn can be configured such thatwhen the horn portion is fully uncurled, the replaceable component hasreached the end of its useful life and should be replaced.

With reference to FIG. 6, in another embodiment, the indicator 50 caninclude an elastic (e.g., stretchable) member 85 connected to a pistonor plunger 70 for slowing the advancement of the piston or plunger 70through a gauge 62. For example, the elastic member 85 can be anchoredto a proximal portion of the gauge 62 and configured to bias the pistonor plunger 70 in the proximal direction P. In this way, the elasticmember 85 restricts advancement of the piston or plunger 70 toward theend-of-use position. Therefore, more fluid must collect in the fluidcollecting portion 66 of the gauge 62 before the piston or plunger 70begins to advance. As in previously-described embodiments, the elasticmember 85 can be tuned to the life cycle for a particular replaceablecomponent of the injector. For example, for replaceable components withrelatively short lifecycles, the elastic member 85 can only slightlybias the piston or plunger 70 so that the piston or plunger 70 freelyadvances through the gauge 62. For replaceable components withparticularly short lifecycles, the indicator 50 may not include anyanchor or stretchable component at all for the piston or plunger 70, asshown, for example, in FIG. 7.

With continued reference to FIG. 6, for replaceable components withlonger lifecycles, the elastic member 85 can be more resistant todeformation, meaning that more force must be applied by pressurizedfluid before the piston or plunger 70 advances. The gauge 62 can includetranslucent or transparent portions so that the injector operator cansee how far the piston or plunger 70 has advanced. The piston or plunger70 can also be a bright color so that it is easily identified by theinjector operator. Markings 86, such as graduations, can be provided onthe gauge 62. The markings 86 can be used to indicate how much time(e.g., number of injection cycles) are left until the piston or plunger70 reaches the end-of-use position indicating that the replaceablecomponent needs to be replaced.

In other embodiments, the disposable life indicator 50 can be replacedwith an electronic sensor for measuring the fluid pressure (e.g., amaximum or average fluid pressure) for each injection performed usingthe replaceable injector component. For example, a high pressure sensorcan be connected to the port 52 and placed in fluid communication withthe MUDS fluid path 134. The pressure sensor can determine fluidpressure for fluid flowing through the MUDS fluid path 134. The pressuresensor can include a wired connection or a wireless transmitter, such asa short range data transmitter using BLUETOOTH®, for sending a signalfrom the sensor to a controller or user interface device. The controlleror user interface device can provide information, such as the measuredpressure of the injection and information about the unused viable lifeof the injector component to the system operator. A suitable pressuresensor that can be connected to the MUDS fluid path 134 and used todetermine lifespan for replaceable injector components is disclosed inU.S. patent application Ser. No. 13/798,709 to Riley et al., whichpublished as Publication No. 2013/0255390 (hereinafter “the '390publication), and which is incorporated by reference herein in itsentirety. As will be discussed in greater detail hereinafter, themeasurements recorded by the high pressure sensor can be used tocalculate the unused viable life for replaceable components of theinjector. The collected measurements and calculated lifespan informationcan be presented to the user or system operator through a userinterface, such as an audio or visual display.

In another embodiment, the injector component is formed from achromogenic plastic configured to change color or tint over time whenexposed to a chemical, such as saline or contrast, or from lack ofexposure to oxygen. In this way, the color or tint of the plasticmaterial of the injector component changes a small amount each time thatinjection fluid is passed through the injector component. The systemoperator can observe the injector component prior to performing aninjection. If the system operator determines that the injector componenthas changed color a sufficient degree, the operator replaces thecomponent with a new one. Alternatively, the injector can includeoptical sensors configured to automatically identify a color change inan injector component. When a sufficient color change is identified, theinjector can instruct the operator to replace the injector component.

In another embodiment, an indicator can include a conductive portionthat is exposed to a weak electrical charge. As in previously describedembodiments of the indicator, the conductive portion is exposed to fluidpassing through the fluid set. The combination of the weak electricalcharge and chemical components of the fluid causes a color changeresponse or reaction, such as oxidation, in the conductive polymerportion of the indicator.

Injector Monitoring System

Having described the fluid injector system 100, replaceable components,such as the MUDS 130, and disposable life indicators 50, the monitoringsystem 10 with automated and/or electronic components for monitoring andproviding feedback about the status of replaceable components will nowbe discussed in detail.

With reference to FIG. 8, the monitoring system 10 includes a controller12 or computing unit, and a feedback device 14. The controller 12 andfeedback device 14 can be a part of the fluid injector 100 and, forexample, located in the injector housing 102. Alternatively, thecontroller 12 and feedback device 14 can be one or more independentelectronic devices remote from and in communication with the injector100. The feedback device 14 includes a user input 31 for obtaininginformation from a system operator, and a display 30 for displayinginformation, such as results obtained from the predictive life algorithmperformed by the controller 12, to the injector operator.

The controller 12 includes a processor 16 with electronic circuitrycapable of performing calculations according to instructions stored oncomputer readable memory 18 associated with the processor 16 or providedto the processor 16 from some external source. The processor 16 can alsoissue instructions and/or requests for information to other electronicdevices, such as sensors, remote electronic databases, data sources, orto the injector 100 for controlling operation thereof. The controller 12can be integrated with the injector 100 and, for example, can beconfigured to perform some or all of the functions of the electroniccontrol device that controls operation of the injector 100. As describedabove, the controller 12 can also be a remote device such as a dedicatedelectronic device, portable computer, or tablet PC. In that case, thecontroller 12 can include either a wired connection to the injector 100or a wireless antenna/transceiver 20 for sending data and instructionsbetween the injector 100 and controller 12.

The monitoring system 10 can also include one or more sensors 22, suchas the high pressure sensor described above and disclosed in the '390publication, for measuring fluid delivery data of the injector 100during fluid injection. Fluid delivery data can include injectionpressure (e.g., maximum fluid pressure) or injection temperature. Themonitoring system 10 can also include a timer 24 for measuring durationof an injection. For example, the timer 24 can include a sensing portionconfigured to identify when fluid flows through the replaceable injectorcomponent, and which is also configured to measure a cumulative fluidflow time. The sensing portion can be in fluid connection with the fluidset or, in other embodiments, can include sensors that identify fluidflow indirectly and without direct fluid contact. For example, thesensing portion can be a vibration sensor for measuring vibrations offlexible tubing or other disposable components, optical sensors formeasuring changes due to light diffraction when fluid is present andflowing through translucent flexible tubing, or sensors for measuringswell of disposable components as fluid passes through the component.Information from the sensors 22 and/or timer 24 is provided to thecontroller 12 for collecting, recording, and analyzing data from a fluiddelivery procedure. In other embodiments, fluid delivery data can beprovided to the controller 12 directly from the electronic controldevice of the injector 100. For example, the controller 12 can determinefluid delivery data based on the injector settings used for theinjection.

With continued reference to FIG. 8, the monitoring system 10 can alsoinclude biological sensors 26, such as conductivity sensors,electrochemical sensors, ion sensors, and the like, configured toidentify contamination in fluid. The biological sensors 26 are in fluidcommunication with the replaceable injector components. For example, thebiological sensors 26 can be positioned in one of the fluid reservoirsor in the fluid path set of the MUDS 130. The biological sensors 26 canbe configured to provide periodic measurements of fluid quality. Ifcontamination is identified, an alert can be provided to the systemoperator with the feedback device 14. In addition, the injector 10 canbe configured not to perform an injection until the contamination alertis addressed.

The monitoring system 10 can also include a number of componentverification or confirmation sensors 28 (referred to as “componentsensors 28”) positioned throughout the MUDS 130. The component sensors28 are configured to automatically identify codes or labels affixed tothe replaceable components (e.g., connector tubing, syringe barrel, orstop cock valve) and to verify that the components are correctlyinstalled and suitable for use with the injector 100. For example, thelabel could include a barcode embedded with information about thecomponent, including the model number, injection parameter limits, andother information for each component. In that case, the component sensor28 can be an image or optical sensor that reads the barcode and extractsinformation therefrom. In some embodiments, the controller 12 can beconfigured to prevent the injector 100 from performing an injectionunless each disposable injector component is verified as being suitable(e.g., correct size and pressure tolerance) for the injection beingperformed. Alternatively, the controller 12 can provide an alert to thesystem operator that a component cannot be verified, but give theoperator the ability to override the alert and perform the injection if,for example, the operator manually identifies that the component isacceptable.

The controller 12 is configured to monitor or track the remaining orunused viable life of replaceable injector components, such as the MUDS130, based on one or more predictive disposable life algorithms Thealgorithm can be stored on the computer readable memory 18 associatedwith the controller or provided to the controller 12 from an externalsource. The algorithms estimate or determine the amount of stress/strainforces (referred to herein as “the accumulated distress”) that thereplaceable injector component has been subjected to and, based on anestimate of the viable life of the replaceable component (i.e., anestimate of the total amount of stress/strain forces that thereplaceable component can withstand before failure), provides anestimate of remaining or unused viable life (i.e., an unused portion ofthe viable life). In some embodiments, the algorithm is based on one ormore models for demonstrating material degradation of a structure. Forexample, the disposable predictive life algorithm can be based onMiner's Rule, which estimates that there is a linear relationshipbetween the number of cycles (e.g., the number of times a force isapplied to an object) and the stress applied during each cycle. Miner'sRule is represented by the following equation:

$\frac{\sum\limits_{i = 1}^{k}\; {n_{i} \times S_{i}}}{W_{Failure}} = C$

In the above equation, n_(i) is the number of cycles and S_(i) is thestress amount for each cycle. W_(Failure) is the total amount of stressthat the system can withstand prior to failure. C is the fraction oflife consumed by the exposure to the n_(i) stress cycles. In the case ofcalculations using Miner's Rule, experimental results demonstrating thefailure stress W must be provided. The controller 12 can obtain theseexperimental values for the replaceable injector component from a lookuptable or computer database. Other non-linear models, such as an inversepower Law-Weibull model, can also be used for purposes of determiningcumulative distress and unused viable life for the replaceable injectorcomponents.

With reference to FIG. 9A, the controller 12 can be configured toperform the following actions or steps to calculate used and/or unusedviable life of a replaceable component and for providing the calculatedinformation to a user.

In one example, as shown in box 210, the controller 12 obtainsinformation indicative of a viable life of a replaceable component of aninjection system. For example, a user can manually enter the viable lifefor a replaceable component to the controller 12. Alternatively, theviable life can be automatically obtained by the controller 12, such as,for example, by downloading viable life for a component of interest froman external electronic device, system, or computer database. In otherexamples, the controller 12 can calculate viable life based, forexample, on the geometry, material properties, location within theinjector (e.g. proximity to a fluid pump or syringe), or function of thereplaceable component of interest.

As shown in box 212, the controller 12 next calculates an accumulatedamount of distress experienced by the replaceable component. Thealgorithm for calculating accumulated distress can be a simple linearrelationship based only on injection force and number of injectioncycles. Alternatively, more complex modeling algorithms taking intoaccount the physical and material properties of the injector component,temperature, and other properties and parameters can also be used withinthe scope of the present disclosure.

The accumulated amount of distress can be based on one or more sets ofpreviously collected injection parameter data associated with eachinjection procedure previously performed on one or more patients withthe fluid injection system. Injection parameter data can includeinformation about an injection, such as maximum or average fluidpressure during the injection, the flow rate, the volume of the fluid,the temperature of the fluid, the duration of the injection, as well asany other information indicative of the stress/strain exerted on thereplaceable component of interest during an injection.

The injection parameter data can also include, for example, data aboutphysical, material, and geometric properties of the replaceablecomponent. The geometric property data can include, for example,information about the size and shape of the fluid container or fluidpath set, such as inner and outer diameters, length, wall thickness,tensile strength, mass, and/or volume thereof.

The material property data can include, for example, information aboutthe formulation and type of polymer used to form the disposable injectorcomponent. In addition to considering material property data about thepolymer material that forms the disposable injector component, fluidproperty data, such as fluid viscosity or concentration, for the fluidbeing injected, can also be considered by the algorithm.

The geometric, material, and fluid property information can be obtainedfrom a variety of sources. For example, property information can beembedded on a label, bar code, QR code, or other computer readableindicator and extracted by the component sensors 28 as described above.The label or indicator can also point to a specific location in a lookuptable or computer database where useful information can be obtained.

The accumulated distress value can be provided in various formsincluding, for example, a distress value or index representing apercentage or amount of degradation for the component of interest.Alternatively, accumulated distress could be provided as a cumulativeamount of force or pressure exerted on the replaceable component byprevious injections. In any case, the calculated accumulated distressdata can be stored in computer readable memory associated with thecontroller 12. The controller 12 can update these stored valuesfollowing each injection to provide a cumulative value corresponding tototal distress to the component.

Information included on the label or in the lookup table and relied onby the controller 12 to calculate accumulated distress can also be usedto ensure that the injector component and fluid to be injected aresuitable for use. For example, the controller 12 can monitor how long aparticular bulk fluid container has been opened or an expiration datefor the fluid contained therein. The controller 12 can be configured toprovide an appropriate warning to a system operator when the fluid to beinjected has expired or is otherwise unsuitable for the injection beingperformed. Similarly, the controller 12 can monitor physical parametersof the injector component and confirm that they are suitable for theinjection being performed.

As shown in box 214, a used portion and/or an unused portion of theviable life for the replaceable component can be determined based on theviable life of the replaceable component, as obtained at box 212, andthe accumulated amount of distress, as calculated at box 214. Inparticular, the unused viable life for the replaceable component isexhausted as accumulated distress increases.

As shown in box 216, feedback about the used and/or unused viable lifefor the replaceable component is provided to the user. For example,feedback can be provided to the user with the visual and/or audiodisplay device 30 (shown in FIGS. 8 and 10). The display device 30 canbe the same display used to show the graphical user interface for theinjector 100. Alternatively, the display can be provided on a remoteelectronic device, such as a computer, tablet PC, smartphone, ordedicated electronic device. Based on the feedback, the user candetermine when the replaceable component should be replaced and, ifnecessary, replace the component prior to performing another injection.

In some examples, the system operator can manipulate the display device30 with a user input 31 (shown in FIG. 8) to select the type ofinformation available and how the information is displayed. For example,a user can select to view a graphical representation of used and/orunused viable life for the replaceable component, for example, in theform of a gas gauge icon or bar graph.

Alternatively or in addition to graphical feedback, feedback can beprovided in the form of numerical representations of used and/or unusedviable life. For example, used and/or unused viable life can be providedas a percentage of viable life remaining. Alternatively, used and/orunused viable life can be provided as a predicted amount of time untilthe component should be replaced (e.g., the disposable injectorcomponent will need to be replaced in three days) or a number ofinjections that can be performed before the disposable injectorcomponent will need to be replaced. These values can be shown asnumerical results and/or with colors indicating injector status. Forexample, a status indicator or icon can be a green color to signify thatthe injector is operating normally and that no components will need tobe replaced in the short term. Yellow indicates that the replaceablecomponent of interest is nearing the end of its lifecycle and should bereplaced soon. Red indicates that the unused viable life of thereplaceable component is nearly exhausted and that the replaceablecomponent should be replaced prior to performing another injection.

In other embodiments, the controller 12 and/or display device 30 canalso be configured to provide a warning, alarm, or alert if the unusedportion of the viable life of the component is nearly exhausted. Forexample, the display device 30 can provide an audible alarm or flashingicon to inform the operator that the component should be replaced beforeanother injection is performed. Similarly, the controller 12 can beconfigured to review programmed inputs for an injection (e.g., injectionpressure and/or flow rate) and to evaluate whether the programmed inputsare too robust for the replaceable injector components based on thecumulative distress endured thus far and unused viable life of thecomponents. If the programmed inputs are too great for the injector, theinjector and/or feedback device can alert the user to replace thereplaceable injector components before performing the injection. If thesystem operator attempts to perform the injection without replacing thecomponent, the controller 12 can automatically reduce programmed inputsto suitable levels to ensure that the injection is performed safely.

With reference to FIG. 9B, a flow chart illustrating a method formonitoring a present or planned use of a replaceable component of aninjector is illustrated. As shown in FIG. 9B, the controller 12 can beconfigured to provide an indication of whether the unused viable life ofa replaceable component of a fluid injector system is sufficient forperforming a planned injection procedure. As in the previously describedexample, the viable life of the replaceable component is provided to thecontroller 12, as shown at box 210.

As shown at box 218, a present set of injection parameters is providedto the controller. As discussed above, injection parameters can includeinformation about an injection, such as maximum or average fluidpressure during the injection, anticipated flow rate, injectionduration, or temperature of the fluid being injected, as well as anyother information indicative of the stress/strain exerted on thereplaceable component of interest during an injection.

As shown at box 220, the controller 12 calculates an estimated amount ofdistress that would be experienced by the replaceable component if aninjection procedure were performed in accordance with the injectionparameters received at box 218. As shown at box 222, the estimatedamount of distress is used to determine a portion of the viable lifethat would be experienced by the replaceable component if the plannedinjection procedure were performed. As shown at box 224, the unusedportion of viable life of the replaceable component can be compared tothe viable life that would be experienced by the replaceable componentif the planned injection procedure were to be performed to determine,for example, if the replaceable component is suitable for the plannedinjection. As shown at box 226, the results of the comparison areprovided to the user. For example, the results could include a simplemessage to the user indicating either that the injection can beperformed (e.g., an indication that the injector is ready for injection)or that the component should be replaced prior to performing theinjection. In other examples, the results can include detailed numericalresults, including the estimated distress experienced during theinjection, unused viable life of the replaceable component, and/orestimated time or number of injections until the component should bereplaced. In other examples, the system can provide an audible alarminforming the user that the replaceable component is not suitable for aplanned injection. In other examples, the controller 12 can beconfigured to prevent an injection from begin performed if the unusedviable life of the component is not sufficient for the plannedinjection.

With reference to FIG. 9C, a flow chart illustrating a method formonitoring status of a replaceable component is illustrated, which takesinto account both accumulated distress and an estimated amount ofadditional distress provided by an injection to be performed. As inpreviously described examples, a viable life for the replaceablecomponent of interest is provided to the controller 12, as shown at box210. As shown at box 212, an accumulated amount of distress experiencedby the replaceable component is calculated. For example, the calculatedaccumulated amount of distress can be based on sets of previouslycollected injection parameter data for injections performed using theinjector and replaceable component of interest. At box 218, a presentset of injection parameter data associated with a planned injection tobe performed by the replaceable component is calculated and, in somecases, provided to the controller 12. At box 220, an estimated amount ofdistress that would be experienced by the replaceable component if theplanned injection were performed is calculated. As shown at box 214, aused and/or an unused portion of the viable life of the replaceablecomponent is calculated based on the accumulated amount of distress. Atbox 222, an estimated portion of the viable life of the replaceablecomponent that would be experienced if the planned injection procedurewere to be performed is calculated. At box 224, the unused portion ofthe viable life of the replaceable component is compared with theadditional portion of the viable life that would be experienced by thereplaceable component if the planned injection were performed todetermine, for example, whether the replaceable component is suitablefor the injection procedure to be performed. At box 226 results of thecomparison are provided to the user in the manner discussed above inconnection with FIG. 9B.

With reference to FIG. 10, in one example, the visual display device 30provides feedback about remaining or unused viable life in the form of avisual indicator 32 providing a graphical representation of remaining orunused viable life of the replaceable component. The visual indicator 32can be in can be in the form of a gas gauge or dial, and can include anarm 34 that rotates between a full position 36 for a newly installedreplaceable component and an empty position 38 when the replaceablecomponent needs to be replaced. Alternatively, the visual indicator 32could be a shape, such as a square or rectangle, having a specific fillamount. The fill amount can decrease following prolonged use to indicatethat remaining or unused viable life of the replaceable component isdecreasing. The fill amount can be color coded such that, as lifeexpectancy decreases, the color of the fill amount changes from green tored. The operator can be instructed to remove and replace the componentwhen the fill color of the visual indicator turns to red.

Having described the monitoring system 10 and a method of calculatingthe remaining or unused viable life of a replaceable component,additional embodiments of the monitoring system 10 will be discussed indetail. With reference again to FIG. 8, in some embodiments, themonitoring system 10 is configured to monitor multiple replaceablecomponents simultaneously and to display feedback with the feedbackdevice 14 about which replaceable component is closest to the end of itsremaining or unused viable life. In this way, the component that is mostin need of replacement (e.g., the weakest link component) can beidentified and replaced. Replaceable components that still have unusedviable life can continue to be used. For example, the controller 12 canbe configured to track unused viable life for a number of thereplaceable components simultaneously. In that case, the feedback device14 can provide a separate remaining viable life indicator or numericalvalue for each replaceable component. The controller 12 can compareremaining viable life for each of these components and highlight theweakest link component. In addition, the feedback device 14 can displaya warning or alert indicating which replaceable component is the weakestlink and when it will need to be replaced.

In other embodiments, the monitoring system 10 can include an imagesensor 40, such as a digital camera, infrared camera, or other knownimaging device, for visually identifying or confirming that portions ofthe releasable component are breaking down. For example, the imagesensor 40 can be configured to obtain images of portions of the injector100 that are known to weaken following prolonged use. In some cases, theobtained images can show cracks or other indications that the componenthas been subjected to substantial stresses and is near the end of itsviable life. In some embodiments, the cracks and other signs of distresscan be identified automatically using image processing techniques, asare known in the art. For example, the image processing techniques canuse color recognition techniques to identify cracks or other stressareas. Distance determination techniques can be used to determine thelength of the cracks or size of the weakened areas. Similarly, thecontroller 12 can be configured to compare a recent image with one ormore previously-obtained images to determine, for example, how fastcracks are expanding and other relevant information about accumulateddistress to the replaceable components. The information obtained byimage processing can be used in conjunction with other cumulativedistress estimates to provide a more sophisticated indication ofremaining or unused viable life for the replaceable injector componentof interest. In particular, if substantial cracking is identified, thecontroller 12 can output an alert indicating that replacement isrequired, even if the algorithm otherwise indicates that the remainingor unused viable life of the component has been exhausted.

In view of the foregoing, it should be apparent to those skilled in theart that the monitoring system 10 of the present invention may bedeployed with apparatuses other than the fluid injector system 100described herein. For example, the monitoring system 10 may be appliedto apparatuses such as infusion devices (e.g., a peristaltic pump, asyringe pump or an elastomeric pump) and centrifuge separators for usein, for example, separating whole blood into its various components(e.g., red blood cells, white blood cells and plasma) and DNA or RNAinto fragments according to their size, and proteins according to theirsize and their charge.

Computing Unit or Device

As previously noted, calculations of remaining or unused viable life forthe one or more replaceable injector components can be calculated by thecontroller 12. The controller 12 can be part of the electroniccontroller device that controls operation of the injector system 100.Alternatively, the controller 12 can be a remote computing device, suchas a personal computer, which includes appropriate processing mechanismsand computer-readable media for storing and executing computer-readableinstructions, such as programming instructions, code, and the like.

With reference to FIG. 11, an exemplary controller (referred to hereinas an electronic device 900) is illustrated. The electronic device 900can include a variety of discrete computer-readable media components.For example, this computer-readable media can include any media that canbe accessed by the electronic device 900, such as volatile media,non-volatile media, removable media, non-removable media, etc. As afurther example, this computer-readable media can include computerstorage media, such as media implemented in any method or technology forstorage of information, such as computer-readable instructions, datastructures, program modules, or other data; random access memory (RAM),read only memory (ROM), electrically erasable programmable read onlymemory (EEPROM), flash memory, or other memory technology; CD-ROM,digital versatile disks (DVDs), or other optical disk storage; magneticcassettes, magnetic tape, magnetic disk storage, or other magneticstorage devices; or any other medium which can be used to store thedesired information and which can be accessed by the electronic device900. Further, this computer-readable media can include communicationsmedia, such as computer-readable instructions, data structures, programmodules, or other data in a modulated data signal, such as a carrierwave or other transport mechanism and include any information deliverymedia, wired media (such as a wired network and a direct-wiredconnection), and wireless media (such as acoustic signals, radiofrequency signals, optical signals, infrared signals, biometric signals,bar code signals, etc.). Of course, combinations of any of the aboveshould also be included within the scope of computer-readable media.

The electronic device 900 further includes a system memory 908 withcomputer storage media in the form of volatile and non-volatile memory,such as ROM and RAM. A basic input/output system (BIOS) with appropriatecomputer-based routines assists in transferring information betweencomponents within the electronic device 900 and is normally stored inROM. The RAM portion of the system memory 908 typically contains dataand program modules that are immediately accessible to or presentlybeing operated on by the processing unit 904, e.g., an operating system,application programming interfaces, application programs, programmodules, program data, and other instruction-based computer-readablecodes.

With continued reference to FIG. 11, the electronic device 900 can alsoinclude other removable or non-removable, volatile or non-volatilecomputer storage media products. For example, the electronic device 900can include a non-removable memory interface 910 that communicates withand controls a hard disk drive 912, e.g., a non-removable, non-volatilemagnetic medium; and a removable, non-volatile memory interface 914 thatcommunicates with and controls a magnetic disk drive unit 916 (whichreads from and writes to a removable, non-volatile magnetic disk 918),an optical disk drive unit 920 (which reads from and writes to aremovable, non-volatile optical disk 922, such as a CD ROM), a UniversalSerial Bus (USB) port 921 for use in connection with a removable memorycard, etc. However, it is envisioned that other removable ornon-removable, volatile or non-volatile computer storage media can beused in the exemplary computing system environment 902, including, butnot limited to, magnetic tape cassettes, DVDs, digital video tape, solidstate RAM, solid state ROM, etc. These various removable ornon-removable, volatile or non-volatile magnetic media are incommunication with the processing unit 904 and other components of theelectronic device 900 via the system bus 906. The drives and theirassociated computer storage media, discussed above and illustrated inFIG. 11, provide storage of operating systems, computer-readableinstructions, application programs, data structures, program modules,program data, and other instruction-based, computer-readable code forthe electronic device 900 (whether duplicative or not of thisinformation and data in the system memory 908).

A user can enter commands, information, and data into the electronicdevice 900 through certain attachable or operable input devices via auser input interface 928. Of course, a variety of such input devices canbe utilized, e.g., a microphone, a trackball, a joystick, a touchpad, atouch-screen, a scanner, etc., including any arrangement thatfacilitates the input of data, and information to the electronic device900 from an outside source. As discussed, these and other input devicesare often connected to the processing unit 904 through the user inputinterface 928 coupled to the system bus 906, but can be connected byother interface and bus structures, such as a parallel port, game port,or a USB. Still further, data and information can be presented orprovided to a user in an intelligible form or format through certainoutput devices, such as a monitor 930 (to visually display thisinformation and data in electronic form), a printer 932 (to physicallydisplay this information and data in print form), a speaker 934 (toaudibly present this information and data in audible form), etc. All ofthese devices are in communication with the electronic device 900through an output interface 936 coupled to the system bus 906. It isenvisioned that any such peripheral output devices be used to provideinformation and data to the user.

The electronic device 900 can operate in a network environment 938through the use of a communications device 940, which is integral to theelectronic device 900 or remote therefrom. This communications device940 is operable by and in communication with the other components of theelectronic device 900 through a communications interface 942. Using suchan arrangement, the electronic device 900 can connect with or otherwisecommunicate with one or more remote computers, such as a remote computer944, which can be a personal computer, a server, a router, a networkpersonal computer, a peer device, or other common network nodes, andtypically includes many or all of the components described above inconnection with the electronic device 900. Using appropriatecommunication devices 940, e.g., a modem, a network interface oradapter, etc., the computer 944 can operate within and communicatethrough a local area network (LAN) and a wide area network (WAN), butcan also include other networks such as a virtual private network (VPN),an office network, an enterprise network, an intranet, the Internet,etc.

As used herein, the electronic device 900 includes, or is operable toexecute appropriate custom-designed or conventional software to performand implement the processing steps of the method and system of thepresent disclosure, thereby forming a specialized and particularcomputing system. Accordingly, the presently-invented method and systemcan include one or more electronic control devices 900 or similarcomputing devices having a computer-readable storage medium capable ofstoring computer-readable program code or instructions that cause theprocessing unit 904 to execute, configure, or otherwise implement themethods, processes, and transformational data manipulations discussedhereinafter in connection with the present disclosure. Still further,the electronic device 900 can be in the form of a personal computer, apersonal digital assistant, a portable computer, a laptop, a palmtop, amobile device, a mobile telephone, a server, or any other type ofcomputing device having the necessary processing hardware toappropriately process data to effectively implement thepresently-invented computer-implemented method and system.

It will be apparent to one skilled in the relevant arts that the systemmay utilize databases physically located on one or more computers whichmay or may not be the same as their respective servers. For example,programming software on computer 900 can control a database physicallystored on a separate processor of the network or otherwise.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A system capable of monitoring a replaceable component thereof, the system comprising: (a) a controller for controlling operation of the system; (b) programming instructions operably associated with the controller according to which the system is configured to (i) accept input of a viable life for a replaceable component of the system; (ii) calculate an accumulated amount of distress experienced by the replaceable component based on each set of previously collected use data associated with each previous use of the replaceable component by the system; and (iii) determine, based in part on the accumulated amount of distress, a used portion of the viable life that the replaceable component has experienced as a result of the previous use or uses thereof and an unused portion of the viable life; and (c) a visual and/or audio feedback device configured to provide to an operator of the system an indication of at least one of the unused and used portions of the viable life of the replaceable component.
 2. The system of claim 1, wherein: (a) the system is a fluid delivery system comprising a fluid injector; and (b) the use data associated with each previous use of the replaceable component by the system is injection parameter data associated with each injection procedure previously performed on one or more patients using the fluid injector; wherein the injection parameter data comprises one or more of an injection pressure, an injection time, and an injection temperature.
 3. The system of claim 2, wherein the replaceable component being monitored by the fluid delivery system comprises at least one of a syringe, a tubing set, a valve, a fluid connector, a multi-patient fluid path set, a single-patient fluid path set and any combination thereof.
 4. The system of claim 2, further comprising a sensing or timing device associated with a portion of the fluid injector and configured to collect the injection parameter data.
 5. The system of claim 1, wherein the accumulated amount of distress is calculated using at least an algorithm that employs a model descriptive of material degradation of the replaceable component.
 6. The system of claim 3, wherein the model is based on Miner's Rule or on an Inverse Power Law-Weibull Model.
 7. The system of claim 1, wherein the use data comprises data collected from multiple portions of the system.
 8. The system of claim 1, wherein the indication of at least one of the unused and used portions of the viable life of the replaceable component comprises displaying a visual representation of the used portion of the viable life relative to the viable life of the replaceable component.
 9. The system of claim 1 wherein the viable life of the replaceable component is determined before the replaceable component is installed on the system.
 10. A method of monitoring a status of a replaceable component of a fluid injector, the method comprising: (a) providing a viable life for the replaceable component; (b) calculating an accumulated amount of distress experienced by the replaceable component based on each set of previously collected injection parameter data associated with each injection procedure previously performed therewith; (c) collecting a present set of injection parameter data associated with a planned injection procedure to be performed with the replaceable component; (d) calculating an estimated amount of additional distress that would be experienced by the replaceable component if the planned injection procedure were to be performed in accordance with the present set of injection parameter data; (e) determining, based in part on the accumulated amount of distress, a used portion of the viable life that the replaceable component has experienced as a result of the previously performed injection procedures and, therewith, an unused portion of the viable life; (f) determining, based in part on the estimated amount of additional distress, an additional portion of the viable life that would be experienced by the replaceable component if the planned injection procedure were to be performed and, as a result, the replaceable component were to incur the estimated amount of additional distress; (g) comparing at least one of the unused and used portions of the viable life of the replaceable component to the additional portion of the viable life that would be experienced by the replaceable component if the planned injection procedure were to be performed; and (h) providing an indication of a result of the comparison to an operator of the fluid injector.
 11. The method of claim 10, wherein the injection parameter data comprises one or more of an injection pressure, an injection time, and an injection temperature.
 12. The method of claim 10, wherein the estimated and the accumulated amounts of distress are each calculated using at least an algorithm that employs a model descriptive of material degradation of the replaceable component.
 13. The method of claim 12, wherein the model is based on Miner's Rule or on an Inverse Power Law-Weibull Model.
 14. The method of claim 10, wherein the injection parameter data comprises data collected from multiple portions of the fluid injector.
 15. The method of claim 10, wherein providing an indication of a result of the comparison comprises displaying a visual representation of the used portion of the viable life relative to the viable life of the replaceable component.
 16. The method of claim 10 wherein the viable life of the replaceable component is determined before the replaceable component is installed on the fluid injector.
 17. The method of claim 10, wherein the replaceable component comprises at least one of a syringe, a tubing set, a valve, a fluid connector, a multi-patient fluid path set, a single-patient fluid path set and any combination thereof.
 18. The method of claim 10, wherein the accumulated amount of distress experienced by the replaceable component will be initially zero when no injection procedure has been previously performed therewith and the planned injection procedure will be intended as the first to be used therewith.
 19. A disposable life indicator for measuring cumulative fluid pressure for a fluid injector, the disposable life indicator comprising: a fluid collecting portion in fluid communication with a fluid set of a fluid injector; and a gauge configured to indicate to a user a used and/or an unused viable life for a replaceable component of the fluid injector based on a volume of fluid in the fluid collecting portion
 20. The disposable life indicator of claim 19, further comprising a check valve disposed between the fluid set of the fluid injector and the fluid collecting portion, the check valve being configured to permit fluid flow above a threshold pressure to access the fluid collecting portion.
 21. The disposable life indicator of claim 20, wherein the check valve is a one-way check valve.
 22. The disposable life indicator of claim 19, further comprising a flow restrictor positioned between the fluid set and the fluid collecting portion for reducing velocity of a fluid flow entering the fluid collecting portion.
 23. The disposable life indicator of claim 22, wherein the flow restrictor comprises a porous filter.
 24. The disposable life indicator of claim 19, wherein the gauge comprises a piston moveably disposed within a bore of the gauge and configured to move therethrough as the volume of fluid in the fluid collecting portion increases.
 25. The disposable life indicator of claim 24, wherein the piston comprises a conspicuous tip configured to extend beyond an open distal end of the gauge in an end-of-use position.
 26. The disposable life indicator of claim 19, wherein the gauge comprises a bourdon tube. 